A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,116
- 试验地点
- 1
- 主要终点
- The occurrence of a major adverse cardiovascular event (MACE)
研究概览
简要总结
Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The ALL-VASCOR study aims to evaluate the efficacy of allopurinol therapy for improving cardiovascular outcomes in patients at high and very high cardiovascular risk, excluding ischemic heart disease. This is particularly important due to the high cost of cardiovascular disease treatment and its status as one of the leading causes of death.
详细描述
The ALL-VASCOR study is a randomized, double-blind, placebo-controlled, multi-center trial that examines the effect of allopurinol therapy (200-500mg of allopurinol daily) versus an equivalent dose of placebo on the risk of cardiovascular events in 1,116 patients aged 40-70, with serum uric acid levels above 5mg/dL and with high and very high risk for cardiovascular disease. The ALL-VASCOR study is further designed to assess the occurrence of long-COVID syndrome. The study is directed toward both primary and secondary as well as additional endpoints. Due to the duration of the study, the planned intervention will end on July 31,2028, unless the Safe Monitoring Board or other applicable authorities decide about it. Participant recruitment for the ALL-VASCOR study is set to begin in August of 2023 and will be conducted only within Poland.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 40-70 years old.
- •Giving informed consent to participate in the study.
- •Serum UA levels above 5 mg/dl within the last six months before the screening visit.
- •Meeting at least one of the criteria defining high or very high CV risk includes:
- •calculated 10-year cardiovascular mortality risk based on SCORE2 >2.5% for patients under 50 years old or ≥5% for patients 50 years old or older
- •documented occurrence of CV diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II (without IHD), PAD, atrial fibrillation (de novo or ever)
- •diabetes or arterial hypertension complicated by organ damage:
- •increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral PWV > 10 m/s;
- •features of left ventricular hypertrophy on echocardiography or electrocardiography;
- •increased urine albumin-creatinine ratio (30-300 mg/g);
- •ankle-brachial index < 0.9.
排除标准
- •Taking allopurinol, febuxostat or other hypouricemic drugs.
- •Contraindications to taking allopurinol.
- •Pregnant women, breastfeeding or planning pregnancy during the duration of the study.
- •Hormonal therapy containing oestrogens.
- •Active cancer process or disease in the last five years, excluding locally malignant tumours.
- •Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs.
- •Renal insufficiency with an eGFR <45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5).
- •Hypothyroidism or hyperthyroidism not in a state of euthyroidism.
- •Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies).
- •Heart failure in NYHA class III and IV.
- •Taking preparations: azathioprine, mercaptopurine or cyclosporin. Participation in another clinical trial of a medicinal product or medical device within the last three months or five half-lives, whichever period is longer.
研究组 & 干预措施
Allopurinol
The patients will receive allopurinol at an initial daily dose of 200 mg. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100 mg (up to 300 mg during V2). Similarly, the dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
干预措施: Allopurinol 200 mg (Drug)
Allopurinol
The patients will receive allopurinol at an initial daily dose of 200 mg. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100 mg (up to 300 mg during V2). Similarly, the dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
干预措施: Optional intervention (Drug)
Placebo
The patients will receive placebo at an initial daily dose of 200 mg. The dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
干预措施: Allopurinol 200 mg (Drug)
Placebo
The patients will receive placebo at an initial daily dose of 200 mg. The dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
干预措施: Optional intervention (Drug)
结局指标
主要结局
The occurrence of a major adverse cardiovascular event (MACE)
时间窗: Baseline up to approximately 5 years
The number of all causes of death, cardiac death, stroke, transient ischemic attack, acute coronary syndrome, coronary angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina or worsening heart failure
次要结局
- Percentage of Participants of all-cause death(Baseline up to approximately 5 years)
- Percentage of Participants With Cardiac Death(Baseline up to approximately 5 years)
- Percentage of Participants With stroke(Baseline up to approximately 5 years)
- Percentage of Participants With transient ischemic attack(Baseline up to approximately 5 years)
- Percentage of Participants With acute coronary syndrome(Baseline up to approximately 5 years)
- Percentage of Participants With coronary angioplasty or revascularization(Baseline up to approximately 5 years)
- Percentage of Participants With peripheral arterial angioplasty(Baseline up to approximately 5 years)
- Percentage of Participants With hospitalization for unstable angina or worsening heart failure(Baseline up to approximately 5 years)
- Percentage of Participants With Hospitalization(Baseline up to approximately 5 years)